Treatment of Fifth Metatarsal Zone 3 Fractures

Not Applicable

Recruiting

• Conditions: Metatarsal Fracture; Fractures, Stress
• Interventions: Procedure: Operative; Other: Walking boot orthosis

• Registration Number: NCT04847115
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-09
• Study Start: 2021-04-10
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2026-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Zone 3 fracture

Exclusion Criteria

• Neuropathy
• Open fractures
• High energy injuries
• Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
• Pressure ulcer(s)
• Lack of consent competence
• Fracture radiologically confirmed more than six months ago
• No possibility of follow-up at one of the study centers
• Established pseudarthrosis
• Medical condition that contraindicates surgery
• Non-compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative	Operative	The patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks.
Non-operative	Walking boot orthosis	The patients in this arm will have non-operative treatment with a walking boot orthosis for six weeks. They will weight bear as tolerated
Operative	Walking boot orthosis	The patients in this arm will be treated operatively with intramedullar screw osteosynthesis. In addition to this, they will weight bear as tolareted in a walking boot orthosis for six weeks.

Primary Outcome Measures

Name	Time	Method
Pain free weight bearing	2 years	Defined as Visual Analoge Scale below 3. The scale range is 0 to 10, where 0 means "no pain" and 10 means "worst pain".

Secondary Outcome Measures

Name	Time	Method
Delayed union	2 years	Rate of delayed unions
Palpatory pain	2 years	Visual Analog Scale below 3
Nonunions	2 years	Rate of nonunions
Level of activity	2 years	Time to normal activity level is resumed
Radiological healing	2 years	Time to radiological callus formation
Work status	2 years	Time of sick leave
Refracture	2 years	Rate of refractures

Trial Locations

Locations (3)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Østfold Hospital Trust; 🇳🇴 Grålum, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway